Label: FACE FACTOR- avobenzone, homosalate, octinoxate, octisalate, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 23, 2015

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone (3.0%), Homosalate (6.0%), Octinoxate (7.5%), Octisalate (5.0%), Titanium Dioxide (3.0%).

  • Inactive ingredients

    Acetyl Hexapeptide-8, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, a-Lipoic Acid, Aqua, Ascorbyl Palmitate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cucumis Sativus (Cucumber) Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Glycrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Potassium Hydroxide, Saccharide Isomerate, Sodium Hyaluronate, Sorbitan Olivate, Stearyl Alcohol, Styrene/Acrylate Copolymer, Zemea Propanediol.

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    Apply liberally 15 minutes before sun exposure

    Reapply ater 40 minutes swimming/sweating, immediately after towel drying, and at least every 2 hours

    Children under 6 months ask a doctor

  • Use

    Helps prevent sunburn

  • Purpose

    sunscreen

  • Warnings

    For external use only

    Do not use on damaged or broken skin

    Stop use and ask doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

    If swallowed get medical help or contact a poison control center right away

  • Package display

    image

  • INGREDIENTS AND APPEARANCE
    FACE FACTOR 
    avobenzone, homosalate, octinoxate, octisalate, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-219-01100 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2015
    Labeler - Kiss My Face, LLC (041794279)
    Registrant - Kiss My Face, LLC (041794279)